Trials of implantable monitoring devices in heart failure: which design is optimal?

Implantable monitoring devices have been developed to detect early evidence of heart failure (HF) decompensation, with the hypothesis that early detection might enable clinicians to commence therapy sooner than would otherwise be possible, and potentially to reduce the rate of hospitalization. In addition to the usual challenges inherent to device trials (such as the difficulty of double-blinding and potential for bias), studies of implantable monitoring devices present unique difficulties because they involve assessment of therapeutic end points for diagnostic devices. Problems include the lack of uniform approaches to treatment in study protocols for device alerts or out-of-range values, and the requirement of levels of evidence traditionally associated with therapeutic devices to establish effectiveness and safety. In this Review, the approaches used to deal with these issues are discussed, including the use of objective primary end points with blinded adjudication, identical duration of follow-up and number of encounters for patients in active monitoring and control groups, and treatment recommendations between groups that are consistent with international guidelines. Remote monitoring devices hold promise for reducing the rate of hospitalization among patients with HF. However, optimization of regulatory approaches and clinical trial design is needed to facilitate further evaluation of the effectiveness of combining health information technology and medical devices.

Costs and cost-effectiveness of carotid stenting versus endarterectomy for patients at increased surgical risk: results from the SAPPHIRE trial.

OBJECTIVES: To evaluate the cost-effectiveness of carotid stenting vs. carotid endarterectomy using data from the SAPPHIRE trial. BACKGROUND: Carotid stenting with embolic protection has been introduced as an alternative to carotid endarterectomy for prevention of cerebrovascular and cardiovascular events among patients at increased surgical risk. METHODS: Between August 2000 and July 2002, 310 patients with an accepted indication for carotid endarterectomy but at high risk of complications were randomized to and subsequently underwent either carotid stenting (n = 159) or endarterectomy (n = 151). Clinical outcomes, resource use, costs, and quality of life were assessed prospectively for all patients over a 1-year period. Life expectancy, quality-adjusted life expectancy, and health care costs beyond the follow-up period were estimated for patients alive at 1 year, based on observed clinical events during the first year of follow-up. RESULTS: Although initial procedural costs were significantly higher for stenting than for endarterectomy (mean difference: $4,081/patient; 95% CI, $3,849-$4,355), mean post-procedure length of stay was shorter for stenting (1.9 vs. 2.9 days; P < 0.001) with significant associated cost offsets. As a result, initial hospital costs were just $559/patient higher with stenting (95% CI, $3,470 less to $2,289 more). Neither follow-up costs after discharge nor total 1-year costs differed significantly. The incremental cost-effectiveness ratio for stenting compared with endarterectomy was $6,555 per quality-adjusted life year (QALY) gained, with over 98 percent of bootstrap estimates < $50,000/QALY gained. CONCLUSIONS: Although carotid stenting with embolic protection is more costly than carotid endarterectomy, by commonly accepted standards, stenting is an economically attractive alternative to endarterectomy for patients at high surgical risk.

Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial.

BACKGROUND: Results of previous studies support the hypothesis that implantable haemodynamic monitoring systems might reduce rates of hospitalisation in patients with heart failure. We undertook a single-blind trial to assess this approach. METHODS: Patients with New York Heart Association (NYHA) class III heart failure, irrespective of the left ventricular ejection fraction, and a previous hospital admission for heart failure were enrolled in 64 centres in the USA. They were randomly assigned by use of a centralised electronic system to management with a wireless implantable haemodynamic monitoring (W-IHM) system (treatment group) or to a control group for at least 6 months. Only patients were masked to their assignment group. In the treatment group, clinicians used daily measurement of pulmonary artery pressures in addition to standard of care versus standard of care alone in the control group. The primary efficacy endpoint was the rate of heart-failure-related hospitalisations at 6 months. The safety endpoints assessed at 6 months were freedom from device-related or system-related complications (DSRC) and freedom from pressure-sensor failures. All analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00531661. FINDINGS: In 6 months, 83 heart-failure-related hospitalisations were reported in the treatment group (n=270) compared with 120 in the control group (n=280; rate 0·31 vs 0·44, hazard ratio [HR] 0·70, 95% CI 0·60-0·84, p<0·0001). During the entire follow-up (mean 15 months [SD 7]), the treatment group had a 39% reduction in heart-failure-related hospitalisation compared with the control group (153 vs 253, HR 0·64, 95% CI 0·55-0·75; p<0·0001). Eight patients had DSRC and overall freedom from DSRC was 98·6% (97·3-99·4) compared with a prespecified performance criterion of 80% (p<0·0001); and overall freedom from pressure-sensor failures was 100% (99·3-100·0). INTERPRETATION: Our results are consistent with, and extend, previous findings by definitively showing a significant and large reduction in hospitalisation for patients with NYHA class III heart failure who were managed with a wireless implantable haemodynamic monitoring system. The addition of information about pulmonary artery pressure to clinical signs and symptoms allows for improved heart failure management. FUNDING: CardioMEMS.

CHAMPION trial rationale and design: the long-term safety and clinical efficacy of a wireless pulmonary artery pressure monitoring system.

BACKGROUND: Decompensated heart failure (HF) is associated with unacceptable morbidity and mortality risks. Recent implantable technology advancements allow frequent filling pressure monitoring and provide insight into HF pathophysiology and a new tool for HF management. METHODS: The CHAMPION trial is a prospective, multicenter, randomized, single-blind clinical trial testing the hypothesis that HF management guided by frequently assessed pulmonary artery pressures is superior to traditional methods. A total of 550 subjects with New York Heart Association (NYHA) functional class III HF were enrolled at 64 sites in the United States. All subjects received the CardioMEMS HF sensor as a permanent pulmonary artery implant and were randomized to the treatment or the control group before discharge. The treatment group received traditional HF management guided by hemodynamic information from the sensor. The control group received traditional HF disease management. Safety endpoints include freedom from device/system-related complications and freedom from HF sensor failure at 6 months. The efficacy endpoint is a reduction in the rate of HF-related hospitalizations in the treatment group versus the control group at 6 months. CONCLUSIONS: The CHAMPION trial will investigate the safety and clinical efficacy of the CardioMEMS hemodynamic monitoring system and may establish this management strategy as a new paradigm for the medical management of patients with symptomatic HF.

Health-related quality of life following carotid stenting versus endarterectomy: results from the SAPPHIRE (Stenting and Angioplasty with Protection in Patients at HIgh Risk for Endarterectomy) trial.

OBJECTIVES: This study compared health-related quality of life in patients undergoing carotid artery stenting (CAS) versus surgical endarterectomy (CEA). BACKGROUND: Carotid artery stenting is approved in the U.S. for treating carotid stenosis in patients at high surgical risk. Whether CAS offers advantages in terms of other patient-centered outcomes is unknown. METHODS: We evaluated health-related quality of life in the SAPPHIRE (Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy) trial, which randomized 334 high-risk patients with carotid stenosis to CAS versus CEA. Health status assessments were obtained at baseline; 2 weeks; and 1, 6, and 12 months after revascularization. Generic measures included the Short-Form-36 (SF-36) (0 to 100 scale), general health rating, and EuroQol (EQ-5D). In addition, we used 6 disease-specific modified Likert scales to assess difficulty with walking, eating/swallowing, driving, headaches, neck pain, and leg pain. RESULTS: In patients treated according to protocol (n = 159 CAS; n = 151 CEA), CAS patients had better scores at 2 weeks for the SF-36 role physical scale (mean difference: 9.0; 95% confidence interval: 0.9 to 17.1; p = 0.031), but these differences had resolved by 1-month follow-up. For the disease-specific scales, CAS patients reported less difficulty eating/swallowing at 2 weeks, less difficulty driving at 2 weeks, and less neck pain at 2 weeks; each of these differences between groups was no longer present at 1 month. No other scores differed between groups at any time point. CONCLUSIONS: Among patients at high surgical risk, CAS was associated with less health status impairment during the first 2 weeks of recovery when compared with CEA. However, these differences had resolved by 1 month after the procedure, and no other differences between revascularization strategies in health-related quality of life were found.

Safety of angioplasty and stenting without thrombolysis for the treatment of early ischemic stroke.

BACKGROUND: Strokes from large-vessel atherosclerotic occlusions or severe stenoses are often resistant to re-canalization with thrombolytic agents. As in acute coronary syndromes, angioplasty and stenting for stroke may be used to achieve timely reperfusion with possibly less risk for hemorrhagic complications. METHODS: From a prospectively collected database, we have retrospectively reviewed cases of patients presenting acutely with an ischemic stroke or subacutely with fluctuating ischemic deficits due to a large-vessel atherosclerotic stenosis and who were treated with angioplasty and stenting without thrombolytics. Endpoints were reperfusion based on the Thrombolysis in Myocardial Infarction (TIMI) score, procedural complications, parenchymal hematoma formation leading to neurologic decline, and 30-day clinical improvement based on the National Institutes of Health Stroke scale (NIHSS). RESULTS: Nine patients with a mean age of 70 +/- 9 years and mean NIHSS of 18.3 +/- 5.0 were treated. Culprit stenotic lesions were located in the extracranial internal carotid artery (ICA) origin (2), intracranial ICA (2), tandem stenosis in the extra- and intracranial ICA (3), and middle cerebral artery (2). Eight patients were treated with angioplasty and adjunctive stenting; one of these patients also required snaring of thrombus from the middle cerebral artery. One patient was treated with angioplasty of an intracranial ICA stenosis alone. TIMI 3 reperfusion was achieved in 8 (88.9%) patients. The mean 30-day improvement in the NIHSS was 15.5 +/- 5.6. Six patients had a NIHSS of 0 or 1 at 30 days. One patient died due to reasons unrelated to stroke or interventional procedure. There were no significant complications or parenchymal hemorrhages. CONCLUSIONS: In appropriately selected patients with ischemic deficits due to large artery atherosclerotic stenoses, angioplasty with adjunctive stenting can be safely performed. Such interventions may improve outcome without the use of thrombolysis.

The optimal treatment of carotid atherosclerosis: a 2008 update and literature review.

Carotid and cerebrovascular disease have major public health implications given the associated morbidity and mortality. However, the best treatment for this disease is uncertain. Carotid endarterectomy has proven useful in primary and secondary prevention of strokes for patients with significant internal carotid artery stenoses. Many patients are considered at high risk for such surgical procedures and therefore have relatively few treatment options. Carotid stenting is currently being investigated as an alternative therapeutic intervention for these patients. This article reviews the literature pertaining to carotid intervention and its current status in 2008.

Long-term results of carotid stenting versus endarterectomy in high-risk patients.

BACKGROUND: We previously reported that, in a randomized trial, carotid stenting with the use of an emboli-protection device is not inferior to carotid endarterectomy for the treatment of carotid artery disease at 30 days and at 1 year. We now report the 3-year results. METHODS: The trial evaluated carotid artery stenting with the use of an emboli-protection device as compared with endarterectomy in 334 patients at increased risk for complications from endarterectomy who had either a symptomatic carotid artery stenosis of at least 50% of the luminal diameter or an asymptomatic stenosis of at least 80%. The prespecified major secondary end point at 3 years was a composite of death, stroke, or myocardial infarction within 30 days after the procedure or death or ipsilateral stroke between 31 days and 1080 days (3 years). RESULTS: At 3 years, data were available for 260 patients (77.8%), including 85.6% of patients in the stenting group and 70.1% of those in the endarterectomy group. The prespecified major secondary end point occurred in 41 patients in the stenting group (cumulative incidence, 24.6%; Kaplan-Meier estimate, 26.2%) and 45 patients in the endarterectomy group (cumulative incidence, 26.9%; Kaplan-Meier estimate, 30.3%) (absolute difference in cumulative incidence for the stenting group, -2.3%; 95% confidence interval, -11.8 to 7.0). There were 15 strokes in each of the two groups, of which 11 in the stenting group and 9 in the endarterectomy group were ipsilateral. CONCLUSIONS: In our trial of patients with severe carotid artery stenosis and increased surgical risk, no significant difference could be shown in long-term outcomes between patients who underwent carotid artery stenting with an emboli-protection device and those who underwent endarterectomy. (ClinicalTrials.gov number, NCT00231270 [ClinicalTrials.gov].).

Durability of endovascular therapy for symptomatic intracranial atherosclerosis.

BACKGROUND AND PURPOSE: Intracranial angioplasty and stenting are therapeutic options for patients with symptomatic intracranial arterial stenoses intractable to medical therapy. However, the long-term safety and clinical efficacy of these techniques are unknown. We sought to assess the long-term outcome and efficacy of these techniques. METHODS: Procedural data and 30-day outcomes were collected from patients treated with coronary balloons and stents for >/=70% atherostenoses. Clinical and radiographic follow-up data were obtained at 30 days, 6 months, 12 months, and yearly thereafter. RESULTS: Fifty-three patients (median age, 67 years; interquartile range [IQR], 58.75 to 75 years) with 69 arterial lesions were treated during a 7-year period. The technical success rate was 98.6% (68/69), with a reduction of the median percent stenosis from 85% (IQR, 70% to 95%) to 0% (IQR, 0% to 26%). In 76.8% (53/69) of the procedures, a stent was implanted. The 30-day death/stroke rate was 10.1% (7/69) with 1 death, and within a median follow-up of 24 months (IQR, 10.25 to 36.5 months), the transient ischemic attack or stroke rate reached 5.8% (4/69). Restenosis rate at 1 year was 15.9% (11/69) and was symptomatic in 18.2% (2/11). The restenosis rate was 50% for angioplasty (8/16) and 7.5% (4/53) for stenting (hazard ratio=5.02; 95% CI, 1.22 to 20.68). Factors associated with restenosis were vessel size <2.5 mm (hazard ratio=4.78; 95% CI, 1.35 to 16.93) and interventions performed in the setting of an acute stroke (hazard ratio=6.36; 95% CI, 1.78 to 22.56). CONCLUSIONS: Intracranial stenting may reduce the rate of recurrent ischemia in patients in whom medical therapy is unsuccessful and is probably more durable than angioplasty alone.

The CAPTURE registry: predictors of outcomes in carotid artery stenting with embolic protection for high surgical risk patients in the early post-approval setting.

BACKGROUND: The use of carotid artery stenting with embolic protection has been practiced for over a decade in the United States, and increasingly so since carotid stenting received FDA approval in 2004. While there have been attempts at establishing predictors of outcomes in carotid artery stenting, they have generally been limited to single center experiences and/or multicenter retrospective surveys. This report examines predictors of outcomes in carotid stenting in the earliest and largest prospective multicenter neurologist-adjudicated experience in the United States post device approval. METHODS: The Carotid Acculink/Accunet Post-Approval Trial to Uncover Unanticipated or Rare Events (CAPTURE) is a prospective, multi-center registry conducted to assess outcomes of carotid artery stenting (CAS) in the noninvestigational setting following device approval for high surgical risk patients (symptomatic with > or =50% stenosis; asymptomatic > or =80% stenosis). A neurologist examined the patients before the procedure, at 24 hr and 30-days post-procedure. The primary endpoint was a composite of death, any stroke, or myocardial infarction within 30-days post-procedure. Strokes and neurological events suspected to be strokes were adjudicated by an independent Clinical Events Adjudication Committee (CEAC) using prespecified definitions. Logistic regression analysis was performed to determine clinical, procedural, and anatomic predictors of endpoint outcomes. RESULTS: Three thousand five hundred patients were enrolled at 144 sites by 353 physicians of varying specialty backgrounds and CAS experience. The 30-day primary endpoint event rate of death, stroke and MI was 6.3% [95% CI: 5.5-7.1%], and the rate of major stroke and death 2.9% [95% CI: 2.4-3.5]. Predictors of adverse outcomes included age, symptomatic patients, predilation prior to embolic protection device placement, time from symptoms to CAS procedure, and the use of multiple stents. CONCLUSIONS: In general, carotid stenting is performed safely in patients with severe stenosis at high surgical risk, with best outcomes in younger asymptomatic patients. However, there are certain patient and procedural characteristics that are associated with poorer outcomes. In these patients, the risk of stenting should be considered vis-à-vis both the anticipated benefit as well as the alternative surgical and medical options.

The CAPTURE registry: analysis of strokes resulting from carotid artery stenting in the post approval setting: timing, location, severity, and type.

BACKGROUND: Although previous reports of carotid stenting with embolic protection (CAS) have focused on clinical outcomes of death, stroke and myocardial infarction, there are few data available characterizing the strokes that occur during CAS, thus limiting understanding of potential mechanisms. This report examines the timing, location, severity, and type of strokes occurring with CAS in the Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Unanticipated or Rare Events (CAPTURE) study. METHODS: The CAPTURE is a prospective, multicenter registry conducted to assess outcomes of CAS in the postapproval setting after device approval. A neurologist examined the patients before the procedure, at 24 hours and 30 days post-procedure. The primary end point was a composite of death, any stroke, or myocardial infarction within 30 days post-procedure. Strokes and all neurologic events suspected to be strokes were adjudicated by an independent Clinical Events Adjudication Committee using prespecified definitions. Source documents of all patients with strokes in this cohort were reviewed. RESULTS: The 30-day results were available for 3500 patients. The 30-day primary end point event rate of death, stroke, and myocardial infarction was 6.3% (95% confidence interval: 5.5%-7.1%), and the rate of major stroke and death was 2.9% (95% confidence interval: 2.4 to 3.5). 4.8% of patients experienced a stroke (3.9% ipsilateral and 0.9% nonipsilateral, 2% major). A majority of stroke symptoms (57.7%) were noted post-procedure and pre-discharge, whereas 22.3% were noted during the procedure and 20% postdischarge. A similar timing distribution regardless of preprocedural symptomatic status was found.Overall, 41% (69 of 170) of all strokes were major. The incidence of major strokes was statistically significantly greater among symptomatic compared with asymptomatic patients, 4.6% (22 of 482) and 1.6% (47 of 3018), respectively. There were more minor than major strokes in asymptomatic patients (63% vs. 37%; P=0.10), whereas stroke severity was equally distributed in symptomatic patients. Among the ipsilateral strokes, almost half (44%) were major, whereas only one-quarter (26%) of the nonipsilateral strokes were major.Overall, 23% of the major strokes were hemorrhagic and 94% of these strokes were noted on the ipsilateral side. There was a tendency toward more major hemorrhagic strokes in symptomatic than in asymptomatic patients (36% vs. 17%; P=0.07). Fifty-four percent of the strokes post-procedure and pre-discharge were major, whereas 27% of the strokes postdischarge were major. Furthermore, 65% of hemorrhagic strokes were noted post-procedure and pre-discharge, 30% postdischarge. CONCLUSIONS: Strokes related to CAS seem to become clinically apparent after the procedure but before discharge in the majority of events. Nevertheless, a significant minority of stroke symptoms follows discharge from the hospital, typically after 24 hours. Timing of stroke after CAS seems to be similar to timing of stroke after carotid endarterectomy. Moreover, nearly 1 in 5 strokes occur in a nonipsilateral distribution, with the exception of intraprocedural events, which were all ipsilateral to the stent being implanted. Hemorrhagic stroke seemed to be more prevalent in the strokes occurring in the post-procedure period. These descriptors of stroke severity, location, and timing may provide insight in to the mechanistic causes of adverse neurologic outcomes in CAS.

Management of carotid artery disease in the high-risk patient with emphasis on the SAPPHIRE study.

Ischemic stroke threatens public health dramatically, and demographic changes promise to continue this epidemic. Although medical advances in risk factor modification, hypertensive control, and antiplatelet therapy have mitigated morbidity and mortality of cerebrovascular disease somewhat, stroke still costs billions in healthcare dollars and reduces quality of life for many patients immeasurably. Carotid endarterectomy has been the standard for invasive management of carotid atherosclerosis, successfully reducing risk of stroke in asymptomatic and symptomatic patients. Despite this, many patients are at high risk for surgical intervention and have unacceptable outcomes. Fortunately, carotid artery stenting offers a less invasive and safer option for these patients. Given the recently published SAPPHIRE trial and other clinical trial data, it is likely that carotid artery stenting will supplant carotid endarterectomy for high-risk patients who require carotid revascularization.

Intensive treatment of hypertension decreases the risk of hyperperfusion and intracerebral hemorrhage following carotid artery stenting.

OBJECTIVES: To assess the efficacy of a comprehensive blood pressure (BP) management protocol in reducing intracerebral hemorrhage (ICH) following carotid artery stenting (CAS). BACKGROUND: Following CAS hyperperfusion syndrome (HPS) can lead to significant morbidity and mortality. Hypertension plays an essential role in its development. METHODS: We instituted a comprehensive BP protocol following the last case of ICH complicating a CAS procedure. All patients received comprehensive monitoring of BP and treatment to a BP < 140/90 mm Hg; those with a treated stenosis >or=90%, contralateral stenosis >or=80%, and hypertension (i.e., risk factors for HPS) were treated to a BP < 120/80 mm Hg. Patients who developed HPS received parenteral beta-blockers or nitrates titrated to resolution of symptoms and discharged when asymptomatic and normotensive. Patients and families were instructed to measure BP twice daily for 2 weeks and to call if hypertension or headache developed. RESULTS: A total of 836 patients had CAS, 266 prior to the comprehensive BP management program and 570 subsequently. The incidence of HPS/ICH was 5/266 (1.9%) patients prior to comprehensive BP management and 3/570 (0.5%) patients afterwards, P = 0.12. The incidence of ICH was 3/266 (1.1%) and 0/570, respectively, P = 0.032. In high-risk patients both HPS and ICH were significantly reduced from 29.4 to 4.2% (P = 0.006) and 17.6-0% (P = 0.006), respectively. There were no complications attributable to the comprehensive program and lengths of hospitalization were similar (2.6 vs. 2.1 days, P = 0.18). CONCLUSIONS: Comprehensive management of arterial hypertension can lower the incidence of ICH and HPS in high-risk patients following CAS, without additional complications or prolonged hospitalizations.

Impact of diabetes mellitus on outcome of patients undergoing carotid artery stenting: insights from a single center registry.

OBJECTIVE: To evaluate the impact of diabetic status on outcome of patients undergoing carotid artery stenting (CAS). BACKGROUND: Diabetes has been demonstrated to be a strong predictor of adverse outcome in patients undergoing coronary revascularization. Its significance in predicting outcome of patients undergoing carotid interventions has not been ascertained. METHODS: We evaluated the short-term outcomes of 833 patients who underwent CAS at our institution. The primary outcome of this analysis was 30 day incidence of stroke, myocardial infarction, and death. RESULTS: Diabetes was present in 311 patients. Baseline characteristics were comparable between diabetics and nondiabetics except for the diabetics having a lower left ventricular ejection fraction, lower hemoglobin, and a higher body mass index at baseline. Further, they were more likely to have congestive heart failure and coronary artery disease. There was no difference in the incidence of stroke (1.9% versus 2.7%,), myocardial infarction (MI) (2.6% versus 1.9%), death (3.9% versus 2.5%), or the composite of death stroke or MI (6.8% versus 5.9%) at 30 days between diabetics and nondiabetics. Similar results were seen when the analysis was restricted to patients treated with an emboli protection device. Diabetes was not a risk factor for adverse outcome after CAS after multivariate adjustment. CONCLUSION: Diabetics undergoing CAS are more likely to have associated co-morbidities. However despite this handicap, their short term outcome after CAS is similar to that of nondiabetics.

The management of renal artery atherosclerosis for renal salvage: does stenting help?

OBJECTIVE: The use of endovascular techniques to treat renal artery stenosis (RAS) has increased in recent years but remains controversial. The purpose of this study was to review the outcomes and durability of percutaneous transluminal angioplasty and stenting (PTA/S) for patients with RAS and decreasing renal function. METHODS: Between 1999 and 2004, 125 consecutive patients underwent angiography and intervention for renal salvage and formed the basis of this study. Inclusion criteria for this study included serum creatinine greater than 1.5 mg/dL, ischemic nephropathy, and high-grade RAS perfusing a single functioning kidney. Patients undergoing PTA/S for renovascular hypertension or fibromuscular dysplasia or in conjunction with endovascular stent grafting for aneurysm repair were excluded. The original angiographic imaging was evaluated for lesion grade and parenchymal kidney size. All medical records and noninvasive testing were reviewed. Preoperative and postoperative patient data were standardized and analyzed by using chi(2) tests for nominal values and t tests for continuous variables. The Modification of Diet in Renal Disease equation was used to estimate glomerular filtration rate (GFR), and univariate analysis was performed. RESULTS: Preoperative variables included the presence of coronary artery disease (93%), diabetes (44%), tobacco use (48%), and hypercholesterolemia (70%). RAS was suspected on the basis of preoperative duplex imaging or magnetic resonance angiography. Aortography and PTA/S were performed in 125 patients (mean age, 71 years; 59% male) with a mean baseline creatinine level of 2.2 mg/dL. There were two mortalities (1.6%) in the 30-day postoperative period, but there was no case of acute renal loss. Blood pressure decreased after PTA/S (151/79 mm Hg before vs 139/72 mm Hg after 1 month; P < .03). For all patients, the estimated GFR went from 33 +/- 12 mL . min(-1) . 1.73 m(-2) (mean +/- SD) to 37 +/- 19 mL . min(-1) . 1.73 m(-2) at 6 months (P = .10). Sixty-seven percent of treated patients had improvement (>10% increase in GFR) or stabilization of renal function. A rapid decline in GFR before intervention was correlated with improvement after PTA/S. Responders after PTA/S had a 27% decrease in GFR before intervention (44 +/- 13 mL . min(-1) . 1.73 m(-2) to 32 +/- 13 mL . min(-1) . 1.73 m(-2); P < .001) with a negative to positive slope change in GFR values. Ten patients underwent reintervention for in-stent restenosis. Cases without improvement in GFR after PTA/S were associated with eventual dialysis need (P = .01; mean follow-up, 19 months). Survival at 3 years was 76%, and dialysis-free survival was 63% as estimated by Kaplan-Meier analyses. CONCLUSIONS: Renal artery stenoses causing renal dysfunction can be safely treated via endovascular means. Rapidly decreasing renal function is associated with the response to renal artery angioplasty/stenting and helps identify patients for renal salvage.

The CAPTURE registry: results of carotid stenting with embolic protection in the post approval setting.

BACKGROUND: Pivotal study data examining carotid stenting with embolic protection as a less invasive alternative to endarterectomy for high surgical risk patients have been acquired under controlled conditions with highly selected physicians and hospitals. This report examines outcomes of carotid stenting post-approval after diffusion of this technology to a broader cross-section of physicians and hospitals. METHODS: The Carotid Acculink/Accunet Post-Approval Trial to Uncover Unanticipated or Rare Events (CAPTURE) is a prospective, multi-center registry to assess two important aspects of the post-IDE experience: the safety of carotid stenting by physicians with varying levels of experience as a measure of the adequacy of physician training, and the identification of rare/unexpected device-related complications. The primary endpoint was a composite of death, any stroke, or myocardial infarction within 30 days post-procedure. RESULTS: 3,500 patients were enrolled by 353 physicians at 144 sites. The 30-day primary endpoint event rate was 6.3% (95% CI: 5.5-7.1%) and did not differ among the three operator experience levels (5.3%, 6.0%, and 7.4%; P = 0.31) from most to least experienced, respectively. There were no differences in outcomes among physician specialties when adjusted for case mix. There were no unanticipated device related adverse events. CONCLUSIONS: The results of the CAPTURE study compare favorably to those achieved in the predicate pivotal investigations, and suggest that the post-approval transfer of this new therapy to the community practice setting via carotid stent training programs is effective in preparing physicians with varying experience levels and specialty training backgrounds.